Clinical thermometers - Performance of electrical thermometers for continuous measurement
1 Scope
This standard specifies the performance requirements for electrical thermometers for continuous measurements.
This standard is applicable to devices that are operated by an electrical power supply either by mains or internal power sources.
The devices can be equipped to accommodate indicators, printing devices, and other auxiliary devices. The requirements for such accessories are not covered by this standard.
Thermometers intended to measure skin temperatures are not covered by this standard.
This standard does not intend to exclude the applicability of any device based on other measuring principles that provides an equivalent performance in continuously measuring body temperature.
Note: Devices can have functions which are covered by different parts of EN 12470 (see Annex A). In this case, it is the responsibility of the manufacturer to indicate by which part of EN 12470 the function is covered, e.g. electrical thermometer with maximum device and exchangeable temperature probes.
2 Normative references
The following documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding any corrigendum), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the document referred to applies.
GB/T 2423.22-2002 Environmental testing for electric and electronic products - Part 2: Test methods Test N: Change of temperature (IEC 60068-2-14: 1984, IDT)
GB/T 2828.2-2008 Sampling procedures for inspection by attributes - Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection (ISO 2859-2:1985, NEQ)
GB 9706.1-2007 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1: 1988, IDT)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011; ISO 0993-1:2009)
YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (ISO 15223:2000, IDT)
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standards: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2: 2001, IDT)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
continuously measuring electrical thermometer
device that continuously measures and displays the temperature of the human body and consists of an indicating unit and a connected temperature probe
